Musculoskeletal News Roundup 9-March-17

March 9, 2017 | Blake Mossy

K2M Group reported 4Q:16 financial results. Total revenue was $61.8 million in 4Q:16, representing an increase of 14% compared to $54.2 million in 4Q:15. Adjusted EBITDA was $0.8 million in 4Q:16, decreasing from $1.3 million in 4Q:15. Gross margin for 4Q:16 decreased to 62.1% compared to 66.3% in 4Q:15. The company's U.S.-based segments grew by: Complex Spine +18%, Minimally Invasive +7% and Degenerative +21% in 4Q:16. The company's U.S. and International segments grew 21% and decreased (3%) respectfully in 4Q:16. International revenues represented 23% of the company's total revenue in 4Q:16. All growth rates are on a constant currency basis.

SeaSpine Holdings reported financial results for 4Q:16. Total revenue was $32.5 million in 4Q:16, representing a decrease of 6% compared to $34.7 million in 4Q:15. Gross margin for 4Q:16 increased to 58.6%, from 52.0% in 4Q:15. The decline in the company's Orthobiologics portfolio was mostly driven by fewer year-end stocking orders, pricing pressures, and product mix-shift to lower cost DBM products. The decline in the company's Spinal Hardware portfolio was driven primarily by lower demand for older products, tepid demand from European markets, and pricing pressures. The company's U.S. segments decreased by: Orthobiologics (6%) and Spinal Fusion Hardware (6%) in 4Q:16 respectively. Overall, U.S. revenue decreased 5% to $29.8 million 4Q:16. All growth rates are on a reported basis.

Vertiflex secured $40 million in a round of financing led by Endeavour Vision and H.I.G BioHealth Patners, with participation from existing investors, New Enterprise Associates, Thomas, McNerney & Partners and Alta Partners. The new capital will be used to support Vertiflex's Superion Indirect Decompression System, a minimally invasive spinal implant designed for the treatment of moderate lumbar spinal stenosis.

K2M entered into an agreement to acquire e-Fellow, a mobile software platform that aims to streamline the patient billing and care process. his transaction is in conjunction with, and augments, K2M's launch of its Balance ACS (BACS), a comprehensive diagnostic and treatment platform that utilizes 3D solutions to help deliver quality outcomes for spine patients across the whole clinical care continuum. Additionally, K2M entered into a partnership with 3D Systems Corporation, a provider of 3D printers, print materials, on-demand manufacturing and software technology to develop exclusive software for the BACS System. With the launch of the Balance ACS platform, partnership with 3D Systems, and the acquisition of e-Fellow, K2M is aiming to supplement its surgical implant portfolio with data driven solutions that provide clinical services and engagement tools to evaluate, analyze and improve patient care and outcomes.

Shoulder Options is preparing to divest its proximal humerus plate portfolio, designed for the treatment of proximal humerus fractures, and for rotator cuff repair. The company intends to divest three products: its AFT Proximal Humerus Fracture Plate, AFT Greater Tuberosity Fracture Plate, and CRP Cuff Repair. With this divestiture, Shoulder Options wants to achieve large scale distribution of these products in order to make them more accessible to a greater number of patients and healthcare providers, and to help fund the commercialization of the company's non-FDA approved, Proteus Shoulder Arthroplasty platform.

Intellijoint Surgical received 510(k) clearance from the FDA for its intellijoint HIP Anterior application, a 3D mini-optical navigational tool. The device aims to provide quantifiable, intraoperative measurements for cup position, leg length, and offset for a direct anterior approach for Total Hip Arthroplasty (THA).

Consensus Orthopedics launched its TracPatch, a wearable monitoring device, offering real-time data, including range of motion, ambulation, exercise compliance, and wound site temperature trends, continuously post-operation. The device is placed on the lower leg just below the joint line and is designed to allow any healthcare provide access to the patient's data. The healthcare provider can monitor the patient's progress and adjust post-surgical activities and rehabilitation goals.

OrthAlign launched its UniAlign system, a handheld navigation device for unicompartmental knee arthroplasty (UKA). The technology is designed to offer surgeons with a minimally invasive approach that provides real-time data, precise bone cuts and minimal pin site morbidity.

Misonix entered into a distribution agreement with Weigao Orthopedic, a medical device company in China specializing in research and development, production and sale of spine, trauma and joint orthopedic implant devices. Under the terms of the agreement, Weigao Orthopedic will sell, market and distribute Misonix's Bone Scalpel in China, Hong Kong, and Macau for five years.

Vertebral Technologies (VTI) appointed three distributors in Germany, Finland and Sweden for the distribution of its InterFuse modular interbody fusion implants. The distributors include Joline GmbH & Co KG, based in Hechingen, Germany, Articular, based in Helsinki, Finland and Anatomica, headquartered in Gothenburg, Sweden. This transaction aims to allow VTI a strengthened global portfolio.

Bio2 Technologies announced the results of ovine interbody fusion study comparing its Vitrium bioactive glass device's capability to support interbody fusion to an implant of similar design constructed from PEEK polymer. The biomechanical tests evaluated each device's effective, safe resorption/bone formation profile, stimulation of new bone formation to increase fusion rates, and its strength to bear physiologic loads. All subjects demonstrated a reduction in motion at 26 weeks indicating a fusion taking place, however Vitrium fusion exhibited a superior adjoining of vertebral bodies. The results indicate Vitrium devices exhibit ideal characteristics of an interbody fusion product.

Vertos Medical received national coverage from the Centers for Medicare & Medicare Services' (CMS) for its mild Procedure designed for the treatment of lumbar spinal stenosis (LSS). The outpatient procedure is minimally invasive, fluroscopically guided through a small portal and requires no general anesthesia, implants or stitches. The system received coverage through a claims-analysis study under CMS and Evidence Development Program.

TheraCell received a patent from the United States Patent and Trademark Office (USPTO) covering its demineralized bone fiber (DBF). The technology incorporates two demineralized cortical fiber allografts, AlloFuse Coritcal FIbers and AlloFuse Fiber Boat, commercialized by AlloSource, for use in surgical procedures.

Alphatec Spine appointed Jeffrey G. Black as Executive Vice President and Chief Financial Officer (CFO). Prior to Alphatec, Mr. Black served as CFO of Applied Proteomics, AltheaDx, and Verenium Corporation. Mr. Black has over 25 years of experience in financial and operations management and will lead the finance, investor relations and account organizations, and architecting the capital structure of the company.